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Sarclisa (Isatuximab For Injection) Now Available In Canada For Patients With Relapsed And Refractory Multiple Myeloma

Published: Jul 8, 2020 7:15 am
  • First and only anti-CD38 anti­body in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) to be approved in Canada1,2
  • SARCLISA™ in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial2
  • Multiple myeloma is the third most common blood cancer in Canada3

Sarclisa (Isatuximab For Injection) Now Available In Canada For Patients With Relapsed And Refractory Multiple Myeloma Mississauga, ON (Press Release) – Sanofi Canada is pleased to an­nounce that Health Canada has approved SARCLISA™ in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of adults with re­lapsed and re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.2

"Immunotherapies like SARCLISA™ leverage the im­mune sys­tem to fight mul­ti­ple myeloma and we're seeing real progress in their ability to help patients. This was not the case over a decade ago," says Dr. Donna Reece, Clinician In­ves­ti­ga­tor, Princess Margaret Cancer Centre.

SARCLISA™ binds to a spe­cif­ic extracellular epitope of CD38 and triggers sev­er­al mech­a­nisms lead­ing to the death of CD38-expressing tumour cells.2

"For Canadian patients living with mul­ti­ple myeloma, who have ex­peri­enced a return of their dis­ease or be­come re­sis­tant to prior treat­ments, it's vital to have new op­tions like SARCLISA™," says Marissa Poole, Country Lead, Canada and General Manager, Sanofi Genzyme. "At Sanofi Genzyme we re­main com­mit­ted to devel­op­ing inno­va­tive med­i­cines that can make a sig­nif­i­cant dif­fer­ence in patients' lives. SARCLISA™ has the po­ten­tial to offer a new standard of care, and we con­tinue to eval­u­ate SARCLISA™ in a com­pre­hen­sive clin­i­cal pro­gram in mul­ti­ple myeloma, as well as in other blood cancers and solid tumours."

Multiple Myeloma Leads to Significant Burden of Disease

Every day, 9 Canadians are diag­nosed with mul­ti­ple myeloma, a cancer of the blood in which ab­nor­mal plasma cells in­ter­fere with nor­mal, healthy blood cell pro­duc­tion and function. The cause is un­known and there is no cure.4

"We en­cour­age patients to play an active role in treat­ment de­ci­sions. But every patient is dif­fer­en­t – their life goals, their dis­ease, the care they re­quire. We must con­tinue to advocate for them and im­prove their access to the ther­a­pies they need," says Martine Elias, Executive Director, Myeloma Canada. "The re­search in myeloma has been promising. We're seeing new ther­a­pies, like SARCLISA™, becoming avail­able to more patients. Every new treat­ment is a move in the right di­rec­tion to help patients live longer and better lives and con­tinue to de­liver hope."

Relapsed (or re­cur­rent) mul­ti­ple myeloma means that the cancer returns after treat­ment or a period of remission. Since mul­ti­ple myeloma does not have a cure, most patients will relapse at some point. Re­frac­tory mul­ti­ple myeloma refers to cancer that does not respond to ther­apy.5

About SARCLISA™

The ap­prov­al of SARCLISA™ by Health Canada was based on the ICARIA-MM study.6 SARCLISA™ added to pom-dex (SARCLISA com­bi­na­tion ther­apy) dem­onstrated a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival (PFS) with a median PFS of 11.5 months com­pared to 6.5 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010).2,6 SARCLISA™ com­bi­na­tion ther­apy also dem­onstrated a sig­nif­i­cantly greater over­all re­sponse rate com­pared to pom-dex alone (60.4% vs. 35.3%, p<0.0001).2

The most common adverse reac­tions (occurring in >20% of patients) in patients who re­ceived SARCLISA™ com­bi­na­tion ther­apy were in­fusion-related reac­tions (38%), pneu­monia (31%), upper res­pira­tory tract in­fec­tions (28%) and diarrhea (26%).2 Abnormal hema­to­logical laboratory re­­sults were evident in patients who re­ceived SARCLISA™ com­bi­na­tion ther­apy, in­clud­ing neu­tro­penia (96%) and febrile neu­tro­penia (12%).2,6 Permanent dis­con­tinu­a­tion of SARCLISA™ com­bi­na­tion ther­apy due to an adverse reac­tion (Grades 3-4) oc­curred in 7% of patients, and 3% of patients dis­con­tinued due to an in­fusion-related reac­tion.2

SARCLISA™ is to be admin­istered as an in­tra­venous (IV) in­fusion at 10 mg/kg, in com­bi­na­tion with pom-dex, every week for four weeks and then every two weeks, until dis­ease pro­gres­sion or un­ac­cept­able toxicity.2

SARCLISA™ con­tinues to be eval­u­ated in mul­ti­ple on­go­ing Phase 3 clin­i­cal trials.

About Sanofi

Life is a health journey and we, at Sanofi, are com­mit­ted to finding thera­peutic solu­tions for the mil­lions of people who are or will be con­cerned by cancer. The num­ber of cancer cases is ex­pected to grow dramatically over the next two decades.

As a health journey part­ner, we, at Sanofi, are rising to the chal­lenge. We are com­mit­ted to fighting cancer through early detection and treat­ments, in­clud­ing pain relief and palliative care. Sanofi Genzyme, our global spe­cial­ty care business unit, has inno­va­tive treat­ments under de­vel­op­ment and is exploring inno­va­tive path­ways to fight cancer.

References

  1. Data on file. Sanofi Genzyme.
  2. PrSARCLISA™ Product Monograph. Sanofi Genzyme. April 29, 2020.
  3. Canadian Cancer Statistics Advisory Com­mit­tee. Canadian Cancer Statistics 2019. Toronto, ON: Canadian Cancer Society; 2019. Available at: cancer.ca/Canadian-Cancer-Statistics-2019-EN (accessed 8 June 2020).
  4. Myeloma Canada. Available at: https://www.myelomacanada.ca/en/about-multiple-myeloma/what-is-myeloma (accessed 27 May, 2020).
  5. National In­sti­tutes of Health. National Cancer In­sti­tute Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/search (accessed 8 June 2020).
  6. Attal M, Richardson PG, Rajkumar SV, et al. Isatuximab plus poma­lido­mide and low-dose dexa­meth­a­sone versus poma­lido­mide and low-dose dexa­meth­a­sone in patients with re­lapsed and re­frac­tory mul­ti­ple myeloma (ICARIA-MM): a ran­domised, multicentre, open-label, phase 3 study. Lancet Oncol. 2019; 394: 2096–107. doi:10.1016/S0140-6736(19)32556-5.

Source: Sanofi Canada.

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